Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer

NCT ID: NCT01789892

Last Updated: 2018-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation

Detailed Description

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PRIMARY OBJECTIVES:

I. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 \[FDG\[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.

OUTLINE:

Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.

After completion of study treatment, patients are followed up for 2 years.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Study Groups

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Diagnostic (methylprednisolone and FDG PET/CT scan)

Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.

Group Type EXPERIMENTAL

methylprednisolone

Intervention Type DRUG

Given IV

fludeoxyglucose F 18

Intervention Type RADIATION

Undergo FDG PET/CT scan

positron emission tomography

Intervention Type PROCEDURE

Undergo FDG PET/CT scan

computed tomography

Intervention Type PROCEDURE

Undergo FDG PET/CT scan

Interventions

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methylprednisolone

Given IV

Intervention Type DRUG

fludeoxyglucose F 18

Undergo FDG PET/CT scan

Intervention Type RADIATION

positron emission tomography

Undergo FDG PET/CT scan

Intervention Type PROCEDURE

computed tomography

Undergo FDG PET/CT scan

Intervention Type PROCEDURE

Other Intervention Names

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Depo-Medrol Medrol MePRDL Solu-Medrol Wyacort 18FDG FDG FDG-PET PET PET scan tomography, emission computed tomography, computed

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
* Undergone clinical FDG PET/CT scan within 14 days of enrollment

Exclusion Criteria

* Prisoners
* Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose \> 180 mg/dl)
* Serious infection within 14 days of enrollment
* Known hypersensitivity to methylprednisolone
* Viral skin lesions
* Immunocompromised ANC(absolute neutrophil count \< 1000/microliter)
* Pregnant/nursing
* History of tuberculosis or systemic fungal disease
* History of steroid psychosis
* Current peptic ulcer disease or diverticulitis
* Corticosteroid use within 14 days of enrollment (including inhaled steroids)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Barker, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Related Links

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Other Identifiers

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NCI-2012-00530

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-10012

Identifier Type: -

Identifier Source: org_study_id

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